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FDA 510(k)

CapnoSpot™ Pneumothorax Decompression Indicator

K-Number: K223625 · 2023-03-28

ApplicantPneumeric, Inc.
Decision Date2023-03-28
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CapnoSpot™ Pneumothorax Decompression Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Pneumeric, Inc.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) number K223625. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CapnoSpot™ Pneumothorax Decompression Indicator?

CapnoSpot™ Pneumothorax Decompression Indicator is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is Pneumeric, Inc.. The 510(k) number is K223625.

When did CapnoSpot™ Pneumothorax Decompression Indicator receive FDA 510(k) clearance?

CapnoSpot™ Pneumothorax Decompression Indicator received FDA 510(k) clearance on 2023-03-28, under 510(k) number K223625.

Who is the listed applicant for CapnoSpot™ Pneumothorax Decompression Indicator?

The FDA 510(k) record lists Pneumeric, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CapnoSpot™ Pneumothorax Decompression Indicator?

The FDA product code for CapnoSpot™ Pneumothorax Decompression Indicator is GAA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related Devices (Code: GAA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102274ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENTArvik Enterprises/ Mini Lap TechnologiesK011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEDiametrics Medical, Inc.K994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESXimed/Prosure/InjectxK983200INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXXimed/Prosure/InjectxK974741MANAN ACCURA NEEDLEMedical Device Technologies, Inc.K962425BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)Radi Medical Systems AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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